Symbol Descriptions
The CE mark and Notified Body
Registration Numbers, the
requirement of Annex II from Medical
Device Directive 93/42/EEC are met.
Please do not dispose of the product in the
household waste at the end of its useful life.
Disposal can take place at appropriate
collection points provided in your country.
Authorized
representative in the
European community
Caution
Follow instructions for use
Manufacturer
BF type applied part
To protect the environment, dispose of empty
batteries at your retail store or at appropriate
collection sites according to national or local
regulations.
Paper Recycling
IP22
Classification for water ingress and
particulate matter.
Manufacturer’s declaration-electromagnetic emissions
The TH09F is intended for use in the electromagnetic environment (for home healthcare) specified below.The customer or the user of the TH09F should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment
–
guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The TH09F uses RF energy only for its internal function. Therefore, its RF emissions are very
low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
The TH09F is suitable for use in all establishments, including domestic establishments and
those directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Manufacturer’s declaration – electromagnetic immunity
The TH09F is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TH09F should
assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment
–
guidance
(for home healthcare environment)
Electrostatic discharge(ESD)
IEC 61000-4-2
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 Kv
Floors should be wood, concrete or ceramic tile. If floors are covered
with synthetic material, the relative humidity should be at least 30%
Power frequency(50, 60 Hz)
magnetic field IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The TH09F power frequency magnetic fields should be at levels
characteristic of a typical location in a typical home healthcare
environment.
Manufacturer’s declaration – electromagnetic immunity
The TH09F is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of the TH09F should
assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment
–
guidance
(for home healthcare environment)
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz
– 2,7 GHz
80 % AM at 1 kHz
10 V/m
80 MHz
– 2,7
GHz
80 % AM at 1
kHz
Recommended separation distance:
d = 1,2
√P
d = 1,2
√P
80MHz to 800 MHz
d = 2,3
√P
800MHz to 2,7 GHz
Where
P
is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer and
d
is the recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site
survey,
a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TH09F is used exceeds the
applicable RF compliance level above, the TH09F should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the TH09F.
